Back to resultsFrozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Corifollitropin alfa
recFSH (follitropin beta)
Sponsored by
About this trial
This is an interventional other trial for Infertility focused on measuring Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
Eligibility Criteria
Inclusion Criteria:
- Participant must have provided written informed consent for the trial.
- Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Corifollitropin alfa 150 μg
recFSH 300 IU
Arm Description
Participants in Base Study P06029 received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.
Participants in the reference group in Base Study P06029 received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.
Outcomes
Primary Outcome Measures
Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).
Secondary Outcome Measures
Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01146418
Brief Title
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Official Title
Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2010 (Actual)
Primary Completion Date
July 24, 2013 (Actual)
Study Completion Date
April 29, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corifollitropin alfa 150 μg
Arm Type
Experimental
Arm Description
Participants in Base Study P06029 received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.
Arm Title
recFSH 300 IU
Arm Type
Active Comparator
Arm Description
Participants in the reference group in Base Study P06029 received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.
Intervention Type
Biological
Intervention Name(s)
Corifollitropin alfa
Intervention Description
Single injection of 150 μg corifollitropin alfa administered under protocol P06029
Intervention Type
Biological
Intervention Name(s)
recFSH (follitropin beta)
Other Intervention Name(s)
Follistim® AQ Cartridge
Intervention Description
Daily recFSH 300 IU administered under protocol P06029.
Primary Outcome Measure Information:
Title
Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
Description
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).
Time Frame
Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
Description
The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.
Time Frame
From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must have provided written informed consent for the trial.
Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
27090863
Citation
Boostanfar R, Gates D, Guan Y, Gordon K, McCrary Sisk C, Stegmann BJ. Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial. Fertil Steril. 2016 Aug;106(2):300-305.e5. doi: 10.1016/j.fertnstert.2016.03.041. Epub 2016 Apr 16.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=P06031&kw=P06031&tab=access
Learn more about this trial
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
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